Purpose of this Study
We are doing this study to find the most effective and safe dose of an experimental drug called LY3537982 (the study drug) for people who have NSCLC that has KRAS G12C mutations.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with Stage 3B-3C or Stage 4 NSCLC that cannot be cured with surgery and radiation</li>
<li>Have evidence of KRAS G12C mutation found in a tumor biopsy or blood sample</li>
<li>Do not have any significant heart disease or a history of heart attack or unstable angina</li>
<li>Do not have any autoimmune disease that’s required systemic treatment in the past 2 years</li></ul>
For more information about who can join this study, please contact the study team at 919-668-4768.
<li>Are diagnosed with Stage 3B-3C or Stage 4 NSCLC that cannot be cured with surgery and radiation</li>
<li>Have evidence of KRAS G12C mutation found in a tumor biopsy or blood sample</li>
<li>Do not have any significant heart disease or a history of heart attack or unstable angina</li>
<li>Do not have any autoimmune disease that’s required systemic treatment in the past 2 years</li></ul>
For more information about who can join this study, please contact the study team at 919-668-4768.
Age Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you decide to participate in this study, you may have a pre-study visit to have a tissue sample taken or blood draw to find out if your cancer has a KRAS mutation.
This study has several different parts to it. The part of the study in which you might be able to participate will depend on when you join the study. Before you make a decision about whether or not you want to join the study, the study team can let you know what part of the study will be open to you.
There is a <strong>Dose Optimization</strong> portion of the study to find out what dose of the study drug should be added to pembrolizumab to help control cancer for a longer period of time compared to receiving the standard of care treatment of pembrolizumab alone. During this part, we will find out if 50 mg or 100 mg of the study drug works better when added to a regimen of pembrolizumab.
The following is a description of the drugs you will receive in this portion of the study. You will get the drugs in 21-day periods called "cycles."<ul>
<li>The study drug, which are capsules that are taken by mouth with or without food twice a day, every day</li>
<li>Pembrolizumab, which is a 30-minute IV infusion that you will receive on the first day of each cycle</li></ul>
You will take part in up to 35 cycles in this portion of the study.
There is a <strong>Safety Lead-In</strong> portion of the study to find out what dose of the study drug should be added to the standard drug combination of pembrolizumab, pemetrexed, and cisplatin or carboplatin for helping control cancer for a longer period of time. The following is a description of the drugs you will receive in this portion of the study:<ul>
<li>The study drug</li>
<li>Pembrolizumab</li>
<li>Pemetrexed, which is a 10-minute IV infusion that you will receive on the first day of each cycle</li>
<li>Cisplatin or carboplatin, which are both IV infusions that you will receive on the first day of each cycle (the study doctor will choose one of these 2 options for you to receive, you will not receive both)</li></ul>
You will take part in up to 35 cycles in this portion of the study. You will get cisplatin or carboplatin for only the first 4 cycles.
In <strong>Part A</strong> of the study, we want to see how well the optimal dose of the study drug works when it is given with pembrolizumab. The following is a description of the drugs you will receive in this portion of the study:<ul>
<li>The study drug -OR- a placebo (inactive substance with no drug in it)</li>
<li>Pembrolizumab</li></ul>
You will take part in up to 35 cycles in this portion of the study. You will get a random assignment (like a coin flip) to either take the study drug or placebo.
In <strong>Part B</strong> of the study, we want to see how well the optimal dose of the study drug works when it is added to the standard drug combination of pembrolizumab, pemetrexed, and cisplatin or carboplatin for helping control cancer for a longer period of time. The following is a description of the drugs you will receive in this portion of the study:<ul>
<li>The study drug -OR- a placebo</li>
<li>Pembrolizumab</li>
<li>Pemetrexed</li>
<li>Cisplatin or carboplatin (the study doctor will choose one of these 2 options for you to receive, you will not receive both)</li></ul>
You will take part in up to 35 cycles in this portion of the study. You will get cisplatin or carboplatin for only the first 4 cycles.
This study has several different parts to it. The part of the study in which you might be able to participate will depend on when you join the study. Before you make a decision about whether or not you want to join the study, the study team can let you know what part of the study will be open to you.
There is a <strong>Dose Optimization</strong> portion of the study to find out what dose of the study drug should be added to pembrolizumab to help control cancer for a longer period of time compared to receiving the standard of care treatment of pembrolizumab alone. During this part, we will find out if 50 mg or 100 mg of the study drug works better when added to a regimen of pembrolizumab.
The following is a description of the drugs you will receive in this portion of the study. You will get the drugs in 21-day periods called "cycles."<ul>
<li>The study drug, which are capsules that are taken by mouth with or without food twice a day, every day</li>
<li>Pembrolizumab, which is a 30-minute IV infusion that you will receive on the first day of each cycle</li></ul>
You will take part in up to 35 cycles in this portion of the study.
There is a <strong>Safety Lead-In</strong> portion of the study to find out what dose of the study drug should be added to the standard drug combination of pembrolizumab, pemetrexed, and cisplatin or carboplatin for helping control cancer for a longer period of time. The following is a description of the drugs you will receive in this portion of the study:<ul>
<li>The study drug</li>
<li>Pembrolizumab</li>
<li>Pemetrexed, which is a 10-minute IV infusion that you will receive on the first day of each cycle</li>
<li>Cisplatin or carboplatin, which are both IV infusions that you will receive on the first day of each cycle (the study doctor will choose one of these 2 options for you to receive, you will not receive both)</li></ul>
You will take part in up to 35 cycles in this portion of the study. You will get cisplatin or carboplatin for only the first 4 cycles.
In <strong>Part A</strong> of the study, we want to see how well the optimal dose of the study drug works when it is given with pembrolizumab. The following is a description of the drugs you will receive in this portion of the study:<ul>
<li>The study drug -OR- a placebo (inactive substance with no drug in it)</li>
<li>Pembrolizumab</li></ul>
You will take part in up to 35 cycles in this portion of the study. You will get a random assignment (like a coin flip) to either take the study drug or placebo.
In <strong>Part B</strong> of the study, we want to see how well the optimal dose of the study drug works when it is added to the standard drug combination of pembrolizumab, pemetrexed, and cisplatin or carboplatin for helping control cancer for a longer period of time. The following is a description of the drugs you will receive in this portion of the study:<ul>
<li>The study drug -OR- a placebo</li>
<li>Pembrolizumab</li>
<li>Pemetrexed</li>
<li>Cisplatin or carboplatin (the study doctor will choose one of these 2 options for you to receive, you will not receive both)</li></ul>
You will take part in up to 35 cycles in this portion of the study. You will get cisplatin or carboplatin for only the first 4 cycles.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Global Pivotal Study in Participants with KRAS G12C-Mutant, Locally Advanced
or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of
LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in those with PD-L1
expression =50% or LY3537982 and pembrolizumab, Pemetrexed, Platinum vs
Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed,
Platinum regardless of PD-L1 Expression. SUNRAY-01
or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of
LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in those with PD-L1
expression =50% or LY3537982 and pembrolizumab, Pemetrexed, Platinum vs
Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed,
Platinum regardless of PD-L1 Expression. SUNRAY-01
Principal Investigator
Jeffrey
Clarke
Protocol Number
PRO00115184
NCT ID
NCT06119581
Phase
III
Enrollment Status
Pending Open to Enrollment